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Life Sciences
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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August 12, 2024
States Want Teva Generic Price Fixing Case Tried 1st
A coalition of state attorneys general suing a slew of generic drugmakers are asking for a Connecticut federal court to proceed with one of the two cases before the other, saying the outcome in that case will have a "significant impact" on settlement talks with other pharmaceutical company plaintiffs.
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August 12, 2024
Glass Tempering Co. Loses Early Exit Bid In NC Patent Fight
A glass processing equipment distributor can't ditch a Finnish competitor's patent infringement suit, a North Carolina federal judge has ruled, finding its rival has sufficiently alleged "exclusionary rights" to the patents for glass tempering.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
States Oppose Shkreli High Court Bid For $64M Disgorgement
State enforcers are opposing a petition from ex-pharmaceutical executive Martin Shkreli asking the U.S. Supreme Court to review a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%
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August 12, 2024
Pacira Patent On Surgery Pain Drug Voided In Win For Generic
Pacira Pharmaceuticals Inc.'s patent on a nonopioid painkiller is invalid, a New Jersey federal judge has ruled, opening the way for generic versions of Exparel, a long-acting injectable for managing postsurgical pain.
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August 12, 2024
King & Spalding Adds Freshfields M&A Ace In Silicon Valley
King & Spalding LLP is expanding its corporate team, announcing Monday it is bringing in a Freshfields Bruckhaus Deringer LLP mergers and acquisitions expert as a partner in its Silicon Valley office.
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August 12, 2024
Del. Judge Says Vaccine IP Claim Actually Mandates Vaccine
Delaware's chief judge was baffled by Alnylam Pharmaceuticals' argument that the word "vaccine" in a patent it claims Pfizer and BioNTech have infringed doesn't actually require a vaccine, leading him to reject the trip down the rabbit hole presented by the company in exchange for "common sense."
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August 12, 2024
The Biggest Georgia Rulings Of 2024 So Far
From upholding a win for a transgender sheriff's deputy who challenged a county health plan's refusal to pay for gender-affirmation surgery, to ruling that a judicial emergency order issued during the pandemic can be used to toll the state's medical malpractice statute of repose, Georgia courts have been busy in the first half of 2024.
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August 12, 2024
Catching Up With Delaware's Chancery Court
Multimillion-dollar share conversions, power struggles in a classic rock band, a good deal for fandom collectibles, and a pindown by two heavyweights were all part of the spectacle in Delaware's Court of Chancery last week. New cases involved pharmaceutical companies, cannabis, drones and liquid-gas exports. In case you missed it, here's the latest from the Chancery Court.
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August 12, 2024
3 Firms Rep As Crown Buys Revance In $924M Deal
Skincare company Crown Laboratories Inc. on Monday announced that it has agreed to merge with aesthetic healthcare biotechnology company Revance Therapeutics Inc. in a $924 million deal built by three law firms.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
Biopharm Co. Alector Sued In Del. For Docs On Director Pay
A stockholder of small cap biopharmaceutical venture Alector Inc has sued the business in Delaware's Court of Chancery for books and records releases, citing company payment of directors at rates roughly twice the amount paid to nonemployee directors of large cap companies in the same sector.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Vidal's Sanctions Make It Clear: Don't Mess With The PTAB
The Patent Trial and Appeal Board has only faced a handful of instances where sanctions took center stage, but the U.S. Patent and Trademark Office director's rulings have made attorneys increasingly aware that pushing ethical boundaries at the board could put their cases and their careers at risk.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen China Evergrande Group file a commercial fraud claim against its founder's ex-wife, legal action by Manolete Partners against the directors of an insolvent construction company, VietJet tackle a claim by French banking group Natixis and more developments in the "Dieselgate" scandal. Here, Law360 looks at these and other new claims in the U.K.
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August 08, 2024
Mass. Atty, 2 Others Settle SEC Insider Trading Claims
A Massachusetts business lawyer, his friend and his friend's father have agreed to collectively pay more than $230,000 to settle the U.S. Securities and Exchange Commission's allegations they used intel to trade ahead of an announcement made by the biotechnology company Frequency Therapeutics Inc., the SEC said Thursday.
Expert Analysis
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.